Multi-billion dollar cannabis drug company GW Pharmaceuticals is set to launch its Epidiolex drug in five European countries after a successful first quarter of sales in the U.S.
The U.K.-based company has also cheered investors by announcing successful trials of the CBD isolate drug for patients suffering from a rare epileptic condition. And, concerns that Epidiolex prescriptions could be curtailed by competition from cheaper, off-the-shelf CBD products, have been dismissed by a leading analyst.
During the first quarter, which ended March 31, GW brought in $39.2 million in revenue, it reported in results to the Nasdaq. Epidiolex, which is the first medicine derived entirely from the cannabis plant to gain Food and Drug Administration approval, generated $33.5 million of that in the U.S. It was also recently approved for clinical trials in Japan.
Positive epilepsy trial result
It is used for the treatment of epileptic seizures associated with Lennox-Gastaut syndrome and Dravet syndrome and GW says Epidiolex has succeeded in a late-stage test of patients with Tuberous Sclerosis Complex (TSC), another form of epilepsy that begins in childhood.
A low dose of Epidiolex daily reduced seizures by 48.6% from baseline. A higher dose cut down on seizures by 47.5%, it told the markets. GW Chief Executive Justin Gover said that it expects to submit an application for the cannabis medicine in TSC in the fourth quarter.
Thousands benefit from Epidiolex
So far, more than 7,600 patients have received Epidiolex prescriptions since its launch, and more than 90% of U.S. patients are now eligible for insurance coverage of Epidiolex, said GW in a news release. In an earnings conference call Christopher John Tovey, GW’s COO, said it was hopeful of securing formal EU commission approval for Epidiolex within the next few months.
He said: “The GW European Commercial Organization is now almost fully in play, in preparation for the early commercial launch markets of France, Germany and the U.K….We then expect to launch in the remaining two major European markets, with specific timing depending on securing appropriate pricing and reimbursement.”
Market bears caution on GW
While the results boosted GW’s stock price market bears have cautioned prospective investors, with Epidiolex having a list price of over $30,000 a year. Their thinking is that with CBD now readily available across numerous jurisdictions, then Epidiolex may be squeezed out by these significantly cheaper, off-the-shelf CBD products.
However Nick Cox, on the Seeking Alpha financial website, disagrees saying: “The lack of legislated product purity and absence of dosage guideline is causing concern.” He says those countries – he mentioned Singapore – with less of an appetite and, or regulatory tailwind for retail CBD use may prefer to look for pharmaceutical solutions with licensed cannabis producers.
“These trends strongly favor drug companies which can bring FDA and EMA approved drugs to market,” Cox continued. “GW Pharmaceuticals is the lead proponent of these at present.”